I. Field of the Invention
The invention relates generally to a disposable adhesive device used for the purpose of securing a subcutaneously inserted intravenous (I.V.) needle in place at the skin and more particularly, to a prefabricated adhesive appliance especially shaped both to facilitate adherence to the hub of the intravenous needle and also to the skin surface to stabilize the position of the needle in relation to the skin, making dislodgement of the needle more difficult.
II. Discussion of the Related Art
In order to deliver intravenous medication and fluid to a patient, one must have vascular access for a period of time ranging from several hours to several days. Vascular access is achieved by introducing a hollow core needle transcutaneously into the lumen of a blood vessel. Normally, the needle is advanced through the skin until the hub of the needle is at the skin surface. If the needle is not sufficiently secured in place, the needle dislodges from the vessel quite easily, thereby requiring repeat of the painful insertion procedure, and possibly tissue damage or necrosis may also result.
In the past, one practice for immobilizing the hub of the needle at the skin interface has included the use of adhesive tape strips criss-crossed about the hub and positioned onto the skin. The number of strips of tape and the manner of application is left to the best judgment of the medical attendant. Yet another commonly used method of attachment has been to place an adhesive backed patch of material over the needle hub and skin. Another method of securing the needle hub to the skin includes laying a patch of adhesive material over the skin and the needle. This method is unstable with respect to the needle orientation and makes the positioned needle subject to easy dislodging from the vein, and increases the likelihood of the needle pulling out of the skin. An additional consideration is that the adhesive is only in contact with a small portion of the needle hub so that there is little resistance to prevent the hub from rotating around its axis. If the hub and the flexible needle are not in alignment, a torsional force on the needle will result which may cause the needle to be dislodged from the blood vessel lumen.
More recently, more sophisticated devices have become available for establishing a subcutaneous angle of an intravenous needle and the securing of the needle in place. One such device is illustrated and described in U.S. Pat. No. 4,627,842 which includes an assembly in which the needle is mounted transversely of the central section of an elongated, flexible, foldable body in which a tapered foam pad having a pressure sensitive adhesive is used to establish the correct needle angle and also position the assembly on the skin of the recipient. In this and other such assemblies, a great deal of attention is paid to supporting and positioning the needle with relative respect to the subcutaneous administration of medication; however, the problem of stabilizing the fixed position of the needle with respect to the skin receives very little consideration. Thus, dislodging of the needle by patient movement or other external causes remains a serious problem with these devices as well as with the customary use of adhesive tape or bandage materials alone. Approaches which have achieved good, repeatable needle placement have a lacked stability with respect to adhesion to the skin; and those approaches which have addressed the problem of adhesion to the skin have been found lacking with respect to securing the needle properly in relation to the lumen of the blood vessel of interest.